SONOPULSE/ SONOPULSE III

K130888 · Ibramed- Industria Brazileria DE Equipamentos Medi · IMI · Jan 9, 2014 · Physical Medicine

Device Facts

• Record ID: K130888
• Device Name: SONOPULSE/ SONOPULSE III
• Applicant: Ibramed- Industria Brazileria DE Equipamentos Medi
• Product Code: IMI · Physical Medicine
• Decision Date: Jan 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Therapeutic Ultrasound - Pain relief . - Reduction of muscle spasms . - Localized increase in blood flow . - Increase range of motion of contracted joints using heat and stretch techniques

Device Story

Sonopulse and Sonopulse III are therapeutic ultrasound devices; deliver 1.1 and 3.3 MHz ultrasound energy via 3cm² or 7cm² transducers. Operator selects treatment via membrane panel with tactile/audio feedback; device provides set-up routine and displays active output status. Used in clinical settings by healthcare providers to treat musculoskeletal conditions. Benefits include pain relief, muscle spasm reduction, increased blood flow, and improved joint range of motion. Operates at 1.1 or 3.3 MHz frequencies with continuous or pulsed (20%, 50% duty cycle) modes; pulse repetition rates of 16Hz, 48Hz, or 100Hz. Maximum treatment time is 30 minutes.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (general safety), IEC 60601-1-2 (electromagnetic compatibility), and IEC 60601-2-5 (ultrasonic physiotherapy equipment) was demonstrated. No clinical data provided.

Technological Characteristics

Therapeutic ultrasound device; 1.1 and 3.3 MHz frequency output; 3cm² or 7cm² transducers. Continuous and pulsed (20%, 50% duty cycle) modes. Pulse repetition rates: 16Hz, 48Hz, 100Hz. Membrane panel interface with tactile/audio feedback. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-5.

Indications for Use

Indicated for patients requiring therapeutic ultrasound for pain relief, reduction of muscle spasms, localized increase in blood flow, and increasing range of motion of contracted joints via heat and stretch techniques.

Regulatory Classification

Identification

An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Predicate Devices

• Sonicator Plus 930 (K013192)

Submission Summary (Full Text)

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## 510(k) Summary

510 (k) Number: K130888 Date of Submission: June 20, 2013

Submitter: IBRAMED EQUIPAMENTOS MEDICOS Avenida Dr. Carlos Burgos 2800 Amparo - Sao Paulo - Brasil

> TEL - 5519-3817-9633 FAX - 5519-7816-7980

# Official Contact:

Tara Conrad TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180

TEL - [phone]

Common Name: Ultrasonic Diathermy Trade Name: Sonopulse; Sonopulse III Class II Classification: Product Code: IMI Classification Panel: Physical Medicine Regulation Numbers: 21 CFR 890.5300 Sonicator Plus 930, ME 930 K013192 Substantial Equivalence:

#### Indications for Use

Therapeutic Ultrasound

- Pain relief .
- Reduction of muscle spams
- Localized increase in blood flow ●
- Increase range of motion of contracted joints using heat and stretch . techniques

#### Device Description

The Sonopulse III offers 1.1 and 3.3MHz ultrasound using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when the buttons are pressed. A provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.

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Image /page/1/Picture/0 description: The image shows the word "IBRAMED" in a bold, sans-serif font. Above the word is a stylized logo consisting of three horizontal bars connected by a vertical element in the center. The logo and the text are both in black, contrasting with the white background.

The Sonopulse offers 1.1 and 3.3MHz ultrasound using a 7cm² or 3cm² transducer. The membrane panel provides both tactile and audio feedback when the buttons are pressed. A provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.

| Features | Subject Devices | | Predicate Device |
|---------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sonopulse by Ibramed | Sonopulse III by<br>Ibramed | Sonicator Plus 930 by<br>Mettler K013192 |
| Indications for Use | Therapeutic Ultrasound | Therapeutic Ultrasound | Therapeutic Ultrasound |
| | Pain relief | Pain relief | Pain relief |
| | Reduction of muscle<br>spams | Reduction of muscle<br>spams | Reduction of muscle<br>spams |
| | Localized increase in<br>blood<br>flow | Localized increase in<br>blood<br>flow | Localized increase in<br>blood<br>flow |
| | Increase range of<br>motion of<br>contracted joints using<br>heat<br>and stretch techniques | Increase range of<br>motion of<br>contracted joints using<br>heat<br>and stretch techniques | Increase range of<br>motion of<br>contracted joints using<br>heat<br>and stretch techniques |
| | | | Neuromuscular<br>Stimulation |
| | | | Symptomatic relief of<br>chronic intractable pain,<br>acute post traumatic<br>pain or acute post<br>surgical pain<br>(interferential and<br>premodulated<br>waveforms) |
| | | | Temporary relaxation of<br>muscle spasms (all<br>waveforms) |
| | | | Prevention of post-<br>surgical<br>phlebo-thrombisis<br>through<br>immediate stimulation<br>of calf muscles (all<br>waveforms) |
| | | | Increase blood flow in<br>the treatment area (all<br>waveforms) |
| | | | Prevention or<br>retardation of<br>disuse atrophy in post |

# Device Comparison Table

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Image /page/2/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED" in a bold, sans-serif font. The symbol is composed of horizontal lines and geometric shapes, creating a modern and abstract design. The overall impression is professional and corporate.

| | | | (all waveforms) |
|---------------------------|------------------------------------------------|------------------------------------------------|--------------------------------------------------------------|
| | | | Muscle re-educations<br>(all waveforms) |
| | | | Maintain or increasing<br>range of motion (all<br>waveforms) |
| | | | Power Source |
| Maximum Treatment<br>Time | 30 minutes | 30 minutes | 30 minutes |
| Frequency | 1.1 MHz ±10%<br>3.2 MHz ±10% | 1.1 MHz ±10%<br>3.2 MHz ±10% | 1.1 MHz ±10%<br>3.2 MHz ±10% |
| Modes | Continuous<br>Pulsed-20% and 50%<br>duty cycle | Continuous<br>Pulsed-20% and 50%<br>duty cycle | Continuous<br>Pulsed-20% duty cycle |
| Pulse Repetition | 100Hz<br>16Hz<br>48Hz | 100Hz<br>16Hz<br>48Hz | 100Hz ±20% |

## Substantial Equivalence

The subject and the predicate devices have the same intended use, the same operating principle, and are similar in their hardware configuration.

#### Technology

The Sonopulse III by Ibramed is a therapeutic ultrasound machine that operates at a 1.1 or 3.3 MHz frequency. The two frequency outputs penetrate to a depth of 5cm and 1 or 2cm respectively.

The Sonopulse by Ibramed is a therapeutic ultrasound machine that operates at a 1.1 or 3.3 MHz frequency. The two frequency outputs penetrate to a depth of 5cm and 1 or 2cm respectively.

# Non-Clinical Testing

This submission includes testing results of the Sonopulse and Sonopulse III. Testing was performed in accordance with the IEC tests submitted in the Declaration of Conformity. The subject and predicate devices have all been tested in accordance with the following IEC tests:

IEC 60601-1: The general standard IEC 60601-1 - Medical equipment|medical electrical equipment - Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. It is used as a bench mark for many electrical medical devices. Both the subject and predicate devices comply with this standard.

The standard contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment.

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Image /page/3/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED" in bold, uppercase letters. The symbol is made up of horizontal lines and a vertical line in the center, creating a geometric design. The overall impression is modern and corporate.

For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone.

IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests

This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. Both the subject and predicate devices comply with this standard.

IEC 60601-2-5: Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

IEC 60601-2-5 applies to the basic safety and essential performance of ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard can also be applied to ultrasonic physiotherapy equipment used for compensation or alleviation of disease, injury or disability. Both the subject and predicate devices comply with this standard.

#### Conclusion

Based on the data and information presented in this submission, the Sonopulse and Sonopulse III are substantially equivalent to the currently legally marketed Sonicator Plus 930. The differences between the subject and predicate devices do not affect the safety or effectiveness of the proposed device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often used as a symbol of medicine. The logo is printed in black ink.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### January 9, 2014

IBRAMED - Industria Brazileria de EQUIPAMENTOS MEDICOS Ltda c/o Tara Conrad TechLink International Consulting 18851 NE 29th Ave. Suite 720 Aventura, Florida 33180 USA

Re: K130888

Trade/Device Name: Sonopulse and Sonopulse III Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Dated: December 17, 2013 Received: December 19, 2013

Dear Ms. Conrad:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Tara Conrad

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K130888

Device Name: Sonopulse and Sonopulse III

Indications For Use:

Therapeutic Ultrasound:

- Pain relief ●
- Reduction of muscle spasms .
- Localized increase in blood flow .
- Increase range of motion of contracted joints using heat and stretch techniques

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C) .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Carlos L. Pena -S

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